Calcitriol or Placebo in Men for Prostate Cancer Active Surveillance

Trial ID or NCT#

NCT00482157

Status

not recruiting iconNOT RECRUITING

Purpose

After the diagnosis of prostate cancer, many men alter their lifestyle or diet or use various supplements in an attempt to retard the growth of their cancer. While there is limited data on the use of diet and supplements to alter the risk of prostate cancer, even less is known regarding the ability of diet or supplements to alter progression. For men who have elected active surveillance, the investigators propose to investigate the ability of vitamin D to retard the growth of prostate cancer.

Official Title

Calcitriol or Placebo in Men for Prostate Cancer Active Surveillance

Eligibility Criteria

Ages Eligible for Study: Older than 45 Years
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - Untreated prostate adenocarcinoma by an extended biopsy (>8 needle cores on systematic prostate biopsy) within 1 year of the screening date - PSA <10.0 ng/ml - Gleason sum 6 or <2 mm Gleason pattern 4 - No more than 33% of biopsy cores positive
Exclusion Criteria:
  1. - Prior or concurrent treatment for prostate cancer - Use of Finasteride, Dutasteride, Saw Palmetto - Use of NSAIDs, COX-2 inhibitors and/or aspirin, soy or vitamin D supplements for more than 7 days over the one month prior to study - Kidney disease, hypercalcemia or renal stones - ECOG performance status >1 - Uncontrolled hypertension, unstable angina, history of transient ischemic attack (TIA), history of stroke.
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Investigator(s)

Sandy Srinivas
Sandy Srinivas
Medical oncologist, Urologic specialist, Genitourinary specialist
Professor of Medicine (Oncology) and, by courtesy, of Urology
David Feldman

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Contact

Cancer Clinical Trials Office CCTO
6504987061

View on ClinicalTrials.gov